38412 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices

to ensure manufactured products meet

their intended requirements. FDA is

committed to publicizing the work

product of the GHTF study groups and

encourages dissemination of these

harmonization documents. Because

FDA intends to utilize this GHTF

document as guidance for the agency

and industry, FDA also is publishing

this document for comment under its

GGP’s. The information and guidance

contained in the draft document is

intended to help manufacturers

understand quality system requirements

that involve process validation and how

process validation relates to product

design and corrective actions.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on global harmonization and process

validation. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the applicable

statute, regulations, or both. The agency has adopted GGP’s, which

set forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This guidance document is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive the ‘‘Draft Global

Harmonization Task Force Study Group

3 Process Validation Guidance’’ via your

fax machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number 2268 followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request. Persons interested in obtaining a copy

of the draft guidance document may

also do so using the World Wide Web

(WWW). The Center for Devices and

Radiological Health (CDRH) maintains

an entry on the WWW for easy access

to information including text, graphics,

and files that may be downloaded to a

PC with access to the Web. Updated on

a regular basis, the CDRH home page

includes ‘‘Draft Global Harmonization

Task Force Study Group 3 Process

Validation Guidance,’’ device safety

alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. The ‘‘Draft

Global Harmonization Task Force Study

Group 3 Process Validation Guidance’’

will be available at ‘‘http://

www.fda.gov/cdrh/comp/

ghtfproc.html’’ and ‘‘http://

www.fda.gov/cdrh/comp/ghtfproc.pdf’’. A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select MEDICAL

DEVICES AND RADIOLOGICAL

HEATLH. From there select CENTER

FOR DEVICES AND RADIOLOGICAL

HEALTH for general information, or

arrow down for specific topics.

IV. Comments

Interested persons may, on or before

August 14, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this draft

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance document and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: July 9, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–19109 Filed 7–14–98; 12:30 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0469]

Draft Guidance for Industry on

Labeling of OTC Topical Drug

Products for the Treatment of Vaginal

Yeast Infections (Vulvovaginal

Candidiasis); Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Labeling Guidance

for OTC Topical Drug Products for the

Treatment of Vaginal Yeast Infections

(Vulvovaginal Candidiasis).’’ The

guidance is intended to provide a

general labeling format for all over-thecounter (OTC) drug products for the

treatment of vaginal yeast infections.

The draft guidance provides

recommendations for both the carton

and the educational brochure.

DATES: Written comments on the draft

guidance may be submitted by October

14, 1998. General comments on the

agency guidances are welcome at any

time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm.’’ Submit written requests for

single copies of the draft guidance

entitled ‘‘Labeling Guidance for OTC

Topical Drug Products for the Treatment

of Vaginal Yeast Infections

(Vulvovaginal Candidiasis)’’ to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your request.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Requests

and comments are to be identified with

the docket number found in brackets in

the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Cheryl A. Turner, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Labeling

Guidance for OTC Topical Drug

Products for the Treatment of Vaginal

Yeast Infections (Vulvovaginal

Candidiasis).’’ Current labeling for such

OTC drug products varies widely among

manufacturers. However, the content to

be communicated in labeling is nearly

identical for each product; thus the

labeling for these products should

convey a clear and consistent message

for the consumer. The intent of this

document is to provide labeling

guidance for all OTC drug products to

treat vaginal yeast infections.

Until 1990, topical drug products for

the treatment of vulvovaginal

candidiasis were available by

prescription only. In 1990, FDA

convened an advisory committee
Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices 38413

meeting to obtain expert on opinion

whether the agency should allow topical

therapies to be made available for OTC

use. The advisory committee

recommended that women whose initial

episode of vulvovaginal candidiasis was

diagnosed and treated by a physician

could adequately self-treat their

condition without the supervision of a

health care provider. The first 7-day

intravaginal drug product for the

treatment of vulvovaginal candidiasis

was approved for OTC use in 1990; the

first 3-day product in 1995; and the first

single-dose product in 1997.

In the Federal Register of February

27, 1997 (62 FR 9024), the agency

published a notice entitled ‘‘Over-theCounter Human Drugs; Proposed

Labeling Requirements,’’ proposing a

standardized format for the labeling of

OTC drug products. This proposed

standardized format is frequently

referred to as the ‘‘Drug Facts Format.’’

The agency is developing this guidance

document on labeling for OTC drug

products for the treatment of vaginal

yeast infections in accordance with the

‘‘Drug Facts Format.’’

Labeling for OTC drug products for

the treatment of vaginal yeast infections

consists of three components: (1) The

carton, (2) the educational brochure,

and (3) the overwrap. With OTC drug

products, the agency believes that

labeling takes on the critical role of

providing information to the consumer.

Therefore, consumers must have

information that is easily understood to

allow for appropriate self-selection and

appropriate use of the product. Since

there are a variety of OTC products

currently available for the treatment of

vaginal yeast infections, and since in

most cases, the content to be

communicated in labeling is nearly

identical for each product, the labeling

for these products should convey a clear

and consistent message to the consumer.

The intent of the draft guidance is to

provide labeling guidance for all OTC

drug products for the treatment of

vaginal yeast infections.

The draft guidance represents the

agency’s current thinking on the

labeling of OTC topical drug products

for the treatment of vaginal yeast

infections. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

Interested persons may, on or before

October 14, 1998, submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. The draft

guidance document and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: July 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18879 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–116, HCFA–

416, HCFA–R–148, and HCFA–R–231]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Clinical

Laboratory Improvement Amendments

(CLIA) Application Form and

Supporting Regulations in 42 CFR

493.1—.2001; Form No.: HCFA–116

(OMB# 0938–0581); Use: These

certification requirements have been

established for any entity that performs

testing on human beings for diagnostic

or treatment purposes. If a laboratory

conducts relatively simple tests that are

categorized as waived or provider

performed microscopy test procedures

(PPMP), it must obtain a certificate of

waiver or certificate of PPMP. If the

laboratory conducts any tests outside of

these two categories, it must apply for

a certificate of compliance or certificate

of accreditation and initially obtain a

registration certificate. These certificates

ensure that laboratories are in

compliance with CLIA.; Frequency:

Biennially; Affected Public: Business or

other for profit, Not for profit

institutions, Federal Government, and

State, local or tribal government;

Number of Respondents: 16,000; Total

Annual Responses: 16,000; Total

Annual Hours: 20,000.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Annual Early

and Periodic Screening, Diagnostic, and

Treatment Services (EPSDT)

Participation Report and Supporting

Regulations in 42 CFR 441.60; Form

No.: HCFA–416 (OMB# 0938–0354);

Use: States are required to submit an

annual report on the provision of

EPSDT services to HCFA pursuant to

section 1902(a)(43) of the Social

Security Act. These reports provide

HCFA with data necessary to assess the

effectiveness of State EPSDT programs.

It is also helpful in developing trend

patterns, national projections,

responding to inquiries, and

determining a State’s results in

achieving its participation goal.;

Frequency: Annually; Affected Public:

State, Local or Tribal Government;

Number of Respondents: 56; Total

Annual Responses: 56; Total Annual

Hours: 1,568.

3. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Limitation on

Provider-Related Donations and Health

Care-Related Taxes; Limitations on

Payments to Disproportionate Share

Hospitals; Medicaid and Supporting

Regulations in 42 CFR 433.68, 433.74,

447.74 and 447.272; Form No.: HCFA–

R–148 (OMB# 0938–0618); Use: These

information collection requirements

specify limitations on the amount of

Federal financial participation available

for medical assistance expenditures in a

fiscal year. States receive donated funds

from providers and revenues are

generated by health care related taxes.

These donations and revenues are used

to fund medical assistance programs.;

Frequency: Quarterly; Affected Public:

State, Local, or Tribal Government;

Number of Respondents: 51; Total

Annual Responses: 51; Total Annual

Hours: #3,892.

4. Type of Information Request:

Revision of a currently approved

collection; Title of Information